House Speaker Lord Allan Velasco has urged the Food and Drug Administration (FDA) to improve the efficiency and promptness of its procedures in the applications of local pharmaceutical companies for certificate of product registration (CPR) and emergency use authorization permits.
“While we understand the need for thorough study of drugs and medicines, we need to balance it out by making compliance easier for local pharmaceutical firms by cutting out unnecessary red tape and redundant requirements,” Velasco said in a statement.
He added that reports of local drug manufacturers whose products had been stuck in regulatory “limbo” for years were increasing.
“These bureaucratic impediments are something that we need to eliminate, especially during a public health crisis,” he said.
Velasco also appealed to the local pharmaceutical industry to boost the country’s capability in the fight against the pandemic, saying that local companies “play a vital role in helping provide much-needed medicines for the prevention and treatment of Covid-19.”
Although FDA allowed some Covid-19 medications to be used for emergencies and be prescribed by doctors, Deputy House Speaker Bernadette Herrera said these medicines were often impossible to obtain.
“Local manufacturers are ready, willing, and able to produce them, but it takes the FDA an inordinately long time to process and approve their requests,” she said.
Based on the FDA checklist, it will take a company a minimum of eight months to complete the requirements needed for the issuance of a CPR.
“Even from a trade and industry perspective, it is alarming that a number of local pharma producers have actually been forced to close, simply because they could no longer afford to wait for the FDA to grant them their permits,” Herrera said. “Can you just imagine how much this dilemma is magnified, now that actual lives are at stake?”
The party-list lawmaker raised the possibility of government support for the pandemic-scarred industry.
“There is an actual and realistic opportunity for us to produce our own medicines that are at par with the ones we are importing,” Herrera said.
“We should throw our support behind these local pharma companies, because the ripple effect will benefit public health, job creation, and overall economic activity,” she added. Jade Veronique V. Yap